Patch-Pump Fluid-Connection Mechanism for Drug Delivery

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Solution Overview

Problem

Patch-pumps require an efficient method to create a fluid connection between a pre-filled drug reservoir and a cannula assembly while maintaining the reservoir's sterility and minimizing activation steps.

Innovation Solution

A mechanism that automatically opens a liquid channel between the pre-filled drug reservoir and the cannula assembly during activation steps, such as removing a safety catch or activating the cannula insertion, using a selectively activatable penetrator and cannula-containing assembly to facilitate drug delivery without a dedicated step for fluid connection.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Adaptability or versatility

If a pre-filled drug reservoir is integrally contained within the patch-pump during manufacturing, then the device achieves miniaturization and enhanced usability, but a dedicated fluid connection step is required which increases device complexity and activation steps

Engineering Contradiction:
ImproveminiaturizationVSAvoidfluid connection mechanism
Core Design Contradiction:
Adaptability or versatilityVSDevice complexity

Solution Approach 1:

The patent combines the fluid connection mechanism with the existing activation mechanism. The penetrator is integrated into the activation assembly, and the actuator that drives cannula insertion also drives the penetrator to pierce the reservoir seal. This merging eliminates the need for a separate fluid connection step while maintaining the pre-filled reservoir's sterility and integrity.

Inventive Principle:
Principle #5Merging (Combining)

2Reliability

If the pre-filled drug reservoir remains sealed until activation, then sterility is maintained, but an additional activation step is required to open the fluid connection

Engineering Contradiction:
ImprovesterilityVSAvoidactivation steps
Core Design Contradiction:
ReliabilityVSEase of operation

Solution Approach 1:

The penetrator is pre-positioned and spring-loaded within the activation assembly during manufacturing. Upon activation, the spring automatically propels the penetrator to pierce the reservoir seal without requiring a separate user action. This preliminary positioning and automatic activation maintains sterility while reducing the number of user steps required.

Inventive Principle:
Principle #10Preliminary action

3Reliability

If a separate dedicated step is used to create fluid connection, then the fluid connection is reliable, but the operation becomes more complex and time-consuming

Engineering Contradiction:
Improvefluid connectionVSAvoidactivation time
Core Design Contradiction:
ReliabilityVSLoss of time

Solution Approach 1:

The patent merges the fluid connection function with the cannula insertion activation. The same actuator that drives the cannula into the patient's skin also drives the penetrator to create the fluid pathway. This simultaneous action ensures reliable fluid connection while eliminating the time required for a separate connection step.

Inventive Principle:
Principle #5Merging (Combining)

4Extent of automation

If the penetrator is spring-loaded for automatic activation, then the fluid connection is created automatically, but the device structure becomes more complex

Engineering Contradiction:
Improveautomatic fluid connectionVSAvoidspring-loaded mechanism
Core Design Contradiction:
Extent of automationVSDevice complexity

Solution Approach 1:

The spring-loaded penetrator mechanism serves multiple functions: it maintains the penetrator in a retracted position during storage, automatically propels the penetrator to pierce the reservoir seal upon activation, and can be integrated with the existing actuator mechanism. This multi-functionality reduces the need for separate mechanisms while achieving automatic fluid connection.

Inventive Principle:
Principle #6Universality (Multi-functionality)

Data Source

PatentUS11013855B2Fluid-connection mechanism and methods for patch-pumps
Publication Date: 2021.05.25 UNITED THERAPEUTICS CORP
  • US11013855B2 patent drawing
  • US11013855B2 patent drawing
  • US11013855B2 patent drawing

AI summary

Embodiments may include a method of delivering a drug. The method may include removing or releasing a structure from a patch-pump assembly. The patch-pump assembly may include a sealed prefilled drug-reservoir, a fluid passageway, a cannula-containing assembly, and a penetrator. The method may also include penetrating the sealed prefilled drug-reservoir containing the drug to establish fluid communication between the sealed prefilled drug-reservoir and a fluid passageway by removing or releasing the structure. The method may further include flowing the drug from the prefilled drug-reservoir to the fluid passageway. In addition, the method may include flowing the drug from the fluid passageway to a cannula-containing assembly. Furthermore, the method may include delivering the drug subcutaneously to a subject using the cannula-containing assembly.